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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Cipla
Cantor Fitzgerald
Harvard Business School
Deloitte
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Baxter

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078722

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NDA 078722 describes CYCLOBENZAPRINE HYDROCHLORIDE, which is a drug marketed by Twi Pharms Inc, Actavis Labs Fl Inc, Aurobindo Pharma, Frontida Biopharm, Invagen Pharms, Jubilant Cadista, Kvk Tech, Mylan Pharms Inc, Orit Labs Llc, Oxford Pharms, Pliva, Prinston Inc, Rubicon Res Pvt Ltd, Sandoz, Sun Pharm Inds Ltd, Upsher-smith Labs, and Watson Labs, and is included in eighteen NDAs. It is available from seventy-eight suppliers. Additional details are available on the CYCLOBENZAPRINE HYDROCHLORIDE profile page.

The generic ingredient in CYCLOBENZAPRINE HYDROCHLORIDE is cyclobenzaprine hydrochloride. There are fifteen drug master file entries for this compound. Eighty suppliers are listed for this compound. Additional details are available on the cyclobenzaprine hydrochloride profile page.
Summary for 078722
Tradename:CYCLOBENZAPRINE HYDROCHLORIDE
Applicant:Sun Pharm Inds Ltd
Ingredient:cyclobenzaprine hydrochloride
Patents:0
Therapeutic Class:Skeletal Muscle Relaxants
Formulation / Manufacturing:see details
Pharmacology for NDA: 078722
Suppliers and Packaging for NDA: 078722
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722 ANDA Aidarex Pharmaceuticals LLC 33261-859 N 33261-859-30
CYCLOBENZAPRINE HYDROCHLORIDE cyclobenzaprine hydrochloride TABLET;ORAL 078722 ANDA Aidarex Pharmaceuticals LLC 33261-859 N 33261-859-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 12, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:May 12, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 12, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Argus Health
Julphar
AstraZeneca
Covington
McKinsey
Chinese Patent Office
Harvard Business School
Cipla

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